- No current organ toxicity > grade 2 according to the NCICTCAE version 4.0, especially
cardiovascular or renal disease (nephrotic syndrome, glomerulopathy, uncontrolled
high blood pressure despite adequate treatment). In case of known or possible cardiac
disease, a cardiological advice will be required prior to the inclusion in the study

- If anticonvulsants are currently administered, the dosing regimen must be stable
within 1 week prior to the first dose of Cilengitide

- If corticosteroids are administered, the dosing regimen must be stable ≥ 5 days prior
to the first dose of Cilengitide.

- Effective contraception for patients (male and female) of reproductive potential
during their entire participation in the study and during 6 months after the last
administration of Cilengitide.

Type of Study:

Study Design:

Outcome Measure:

Determination of the Maximal Tolerated Dose of Cilengitide

Outcome Description:

A DLT is defined below:
Hematological toxicity:
grade 4 neutropenia for more than 5 days
grade 3 or 4 neutropenia with documented infection
grade 3 or 4 thrombopenia for more than 5 days
requirement of platelet transfusion support for more than 5 days
Non-hematological toxicity:
Any grade 3 or 4 non-hematological toxicity of whatever duration with the exception of (i) nausea/vomiting without appropriate treatment, and (ii)isolated, transient fever occurring outside an episode of neutropenia), with the exclusion of toxicities related to any other well-identified cause.

NCT ID:

Start Date:

Completion Date:

Related Keywords:

Name

Location

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